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Clinical Operations Lead – Clinical Trial Manager
Location
India
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Operations Lead – Clinical Trial Manager
Alimentiv
• Responsible for the clinical operations of a project within a defined regional/global level. • Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites. • The COL acts as a primary liaison between the CRAs and the clinical project team. • Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs. • Implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation. • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • Develop study tools for site and CRA use, review visit reports, review and track protocol deviations. • Support other objectives for clinical operations and the clinical project team.
Job Requirements
- College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
- OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
- Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
- Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Benefits
- Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle.
- PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media.
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